Cognitive-behavioral, behavioural and mindfulness-based therapies for insomnia in menopause.

OBJECTIVES: Insomnia is frequently reported by women during menopause due to physiological changes and environmental factors and is associated with negative daytime sequelae. Due to medication side effects and patient preferences, there is increased interest in the use of psychological treatments for menopausal insomnia. The primary objective of this review is to review the efficacy of cognitive-behavioral, behavioral, and mindfulness-based (CBBMB) therapies in treating insomnia in peri- and post-menopausal women. The secondary objective is to review the effect of CBBMB therapies on relevant secondary outcomes to gain a comprehensive understanding of their impacts. METHODS: We conducted a narrative review of the literature. A search of PubMed and Google Scholar was conducted between January 2020 and March 2021. RESULTS: Cognitive-behavioral therapy (CBT) for insomnia is efficacious, with corollary improvements in mood, functional outcomes and potential mechanistic factors (e.g., unhelpful beliefs). Sleep restriction therapy is also efficacious, with somewhat poorer effects on secondary outcomes relative to CBT. Mindfulness meditation and relaxation for insomnia demonstrated promise, but its long-term effects remain unknown. CONCLUSIONS: Research with more diverse samples and head-to-head comparisons is needed. Dissemination of CBBMBs for insomnia in clinics where menopausal women seek care is an important next step.

Psychometric properties of the difficulties in emotion regulation Scale in a perinatal sample.

BACKGROUND: One in five pregnant and postpartum individuals experience an anxiety, depressive, and/or trauma-related disorder. Emotion dysregulation (ED) underlies the development and maintenance of various mental health disorders. The Difficulties in Emotion Regulation Scale (DERS) is the most comprehensive and commonly used measure of emotion dysregulation, yet limited evidence supports its use in the perinatal population. The present study aims to evaluate the validity of the DERS and its six subscales in a perinatal sample and to assess its predictive utility in identifying perinatal individuals with a disorder characterised by emotion dysregulation. METHODS: Pregnant and postpartum individuals (N = 237) completed a diagnostic clinical interview and self-report measures of anxiety, depression, and perceived social support. RESULTS: The DERS subscales demonstrated good internal consistency and construct validity, as it strongly correlated with measures of anxiety and depression and failed to correlate with a measure of perceived social support. Results from an exploratory factor analysis supported a 6-factor solution, suggesting structural validity. An ROC analysis revealed good to excellent discriminative ability for the DERS full scale and four of the subscales. Finally, an optimal clinical cut-off score of 87 or greater was established with a sensitivity of 81% for detecting a current anxiety, depressive, and/or trauma-related disorder. CONCLUSIONS: This study provides evidence for the validity and clinical utility of the DERS in a treatment-seeking and community sample of pregnant and postpartum individuals.

Psychometric properties of the PSWQ in a sample of pregnant and postpartum women.

BACKGROUND: Generalized anxiety disorder (GAD)-characterised by excessive and uncontrollable worry-is the most frequently diagnosed anxiety disorder during pregnancy and the postpartum period. Identification of GAD often relies on assessment of its cardinal feature, pathological worry. The Penn State Worry Questionnaire (PSWQ) is the most robust measure of pathological worry to date but has not been extensively evaluated for use during pregnancy and the postpartum period. This study evaluated the internal consistency, construct validity, and diagnostic accuracy of the PSWQ in a sample of pregnant and postpartum women with and without a principal GAD diagnosis. METHODS: One hundred forty-two pregnant and 209 postpartum women participated in this study. Sixty-nine pregnant and 129 postpartum participants met criteria for a principal diagnosis of GAD. RESULTS: The PSWQ demonstrated good internal consistency and converged with measures assessing similar constructs. Pregnant participants with principal GAD scored significantly higher on the PSWQ than those with no psychopathology and postpartum participants with principal GAD scored significantly higher than those with principal mood disorders, other anxiety and related disorders, and no psychopathology. A cut-off score of 55 and 61 or greater was determined for detecting probable GAD during pregnancy and the postpartum period, respectively. Screening accuracy of the PSWQ was also demonstrated. CONCLUSIONS: This study underscores the robustness of the PSWQ as a measure of pathological worry and probable GAD and supports its use in the detection and monitoring of clinically significant worry symptoms during pregnancy and postpartum period.

Characterizing worry content and impact in pregnant and postpartum women with anxiety disorders during COVID-19.

The novel COVID pandemic has had a substantial impact on global mental health, including those populations that are inherently vulnerable such as pregnant and postpartum (perinatal) women. Anxiety disorders (ADs) are the most common mental health disorders during the perinatal period, affecting up to one in five women. However, since the onset of the pandemic, up to 60% of perinatal women are experiencing moderate to severe levels of anxiety. Given the substantial increase in perinatal anxiety during COVID, we sought to better understand its phenomenology by characterizing the collective worry content and impact of COVID using a content analysis. Eighty-four treatment-seeking pregnant (n = 35) and postpartum (n = 49) women with a principal AD, participated in this study between April and October 2020. In addition to completing questionnaire measures and a semistructured diagnostic interview, participants were asked to (1) describe their top excessive and uncontrollable worries, (2) describe additional COVID and non-COVID worries, and (3) describe how the pandemic had affected their lives. All responses were given verbally and transcribed verbatim by assessors. A content analysis led to the emergence of various COVID and non-COVID worry and impact themes. One third of participant's principal worries were specific to COVID, and 40% of COVID worries were specific to the perinatal context. Understanding the worry content and impact of COVID may improve symptom detection and inform the development of targeted treatment strategies to support the mental health needs of perinatal women with ADs throughout the pandemic and thereafter. Understanding pandemic-specific worries is important for perinatal symptom screening and may allow for the development of targeted treatment strategies to address COVID-specific worries and impact.

Validation of the intolerance of uncertainty scale as a screening tool for perinatal anxiety.

BACKGROUND: To date, there is a significant lack of research validating clinical tools for early and accurate detection of anxiety disorders in perinatal populations. Intolerance of uncertainty was recently identified as a significant risk factor for postpartum anxiety symptoms and is a key trait of non-perinatal anxiety disorders. The present study aimed to validate the Intolerance of Uncertainty Scale (IUS) in a perinatal population and evaluate its use as a screening tool for anxiety disorders. METHODS: Psychiatric diagnoses were assessed in a sample of perinatal women (n = 198), in addition to completing a self-report battery of questionnaires. Psychometric properties including internal consistency and convergent and discriminant validity were assessed. Determination of an optimal clinical cut-off score was measured through a ROC analysis in which the area under the curve, sensitivity, specificity, as well as positive and negative predictive values were calculated. RESULTS: The IUS demonstrated excellent internal consistency (α = 0.95) and an optimal clinical cut-off score of 64 or greater was established, yielding a sensitivity of 89%. The IUS also demonstrated very good positive (79%) and negative (80%) predictive values. CONCLUSIONS: These findings suggest that the IUS represents a clinically useful screening tool to be used as an aid for the early and accurate detection of perinatal anxiety.

Cognitive behavioral therapy for perinatal anxiety: A randomized controlled trial.

BACKGROUND: Up to one in five women meet diagnostic criteria for an anxiety disorder during the perinatal period (i.e. pregnancy and up to 1 year postpartum). While psychotropic medications are effective, they are associated with risks for mothers and babies. There is a growing demand for evidence-based non-pharmacological treatments for perinatal anxiety. OBJECTIVE: To evaluate the effectiveness of a cognitive behavioral group therapy protocol for perinatal anxiety. METHODS: In total, 96 women were randomized to cognitive behavioral group therapy or waitlist at a clinic specializing in women's mental health. Participants were 22-41 years of age, pregnant or up to 6 months postpartum and had an anxiety disorder with or without comorbid depression. RESULTS: Compared to waitlist, participants in cognitive behavioral group therapy reported significantly greater reductions in the primary outcome of anxiety (State-Trait Inventory of Cognitive and Somatic Anxiety, η2p = .19; Hamilton Anxiety Rating Scale, η2p = .16), as well as in secondary outcomes including worry (Penn State Worry Questionnaire, η2p = .29), perceived stress (Perceived Stress Scale, η2p = .33) and depressive symptoms (Edinburgh Postnatal Depression Scale, η2p = .27; Montgomery-Åsberg Depression Rating Scale, η2p = .11). Maternal status (pregnant, postpartum) and medication use were unrelated to treatment outcomes. All gains were maintained, or continued to improve, at 3-month follow-up. CONCLUSION: Cognitive behavioral group therapy was effective in improving anxiety and related symptoms among women with anxiety disorders in the perinatal period.

Characterizing the nature of worry in a sample of perinatal women with generalized anxiety disorder.

Prevalence of perinatal anxiety disorders continues to grow, with estimates greater than those of postpartum depression. Generalized anxiety disorder (GAD) is the most commonly reported perinatal anxiety disorder, yet very little is known about the worry content experienced during the perinatal period in those with GAD. This study investigated worry content and frequency in a sample of perinatal women (n = 20) and age-matched nonperinatal women (n = 20) diagnosed with GAD. Participants completed the Penn State Worry Questionnaire (PSWQ) to assess worry severity, in addition to providing their current top worries. Mean scores on the PSWQ in both samples exceeded a clinical cut-off score of 65, and thematic analyses revealed that perinatal women experienced significantly greater parental-themed worries compared with the nonperinatal GAD sample (p < .05). Capturing the unique content of worry for perinatal woman will assist clinicians in identifying treatment targets and may enhance treatment outcome.

Cognitive-behavioral group treatment for perinatal anxiety: a pilot study.

Along with physical and biological changes, a tremendous amount of upheaval and adjustment accompany the pregnancy and postpartum period of a woman's life that together can often result in what is commonly known as postpartum depression. However, anxiety disorders have been found to be more frequent than depression during pregnancy and at least as common, if not more so, during the postpartum period, e.g., Brockington et al., (Archieves Women's Ment Health 9:253-263, 2006; Wenzel et al. (J Anxiety Disord, 19:295-311, 2005). Cognitive-behavioral therapy (CBT) is a well-established psychological treatment of choice for anxiety; however, few studies have specifically examined a cognitive-behavioral intervention targeting perinatal anxiety. This pilot study examined the effectiveness of a cognitive-behavioral group treatment (CBGT) program specifically tailored to address perinatal anxiety in 10 women who were either pregnant or within 12 months postpartum. Participants were recruited from a women's clinic at an academic hospital setting, with anxiety identified as their principal focus of distress. Following a diagnostic interview confirming a primary anxiety disorder and completion of assessment measures, participants completed a 6-week CBGT program. There was a statistically significant reduction in anxiety and depressive symptoms following the CBGT program (all p < 0.05). Participants also reported high acceptability and satisfaction with this treatment for addressing their perinatal anxiety. These findings suggest that CBGT for perinatal anxiety is a promising treatment for both anxiety and depressive symptoms experienced during the perinatal period. Further studies are needed to evaluate the treatment efficacy through larger controlled trials.

Cognitive Behavioural Therapy for insomnia decreases the discrepancy between objective and subjective measures of sleep.

INTRODUCTION: Individuals with insomnia disorder often exhibit differences between reported experiences of sleep and objectively measured sleep parameters; however, the implications of this subjective-objective sleep discrepancy during treatment remains unclear. OBJECTIVE: The aim of this study was to investigate the impact of cognitive behavioural therapy for insomnia (CBT-I) on the discrepancy between objective and subjective measures of sleep, and to assess whether changes in clinical variables such as depression, anxiety, fatigue, and beliefs about sleep, were related to changes in discrepancy. METHODS: Twenty-five participants with insomnia disorder were enrolled in group CBT-I. Sleep measures were continually sampled from baseline until 2 weeks post-treatment with both objective (i.e., actigraphy) and subjective (i.e., sleep diary) methods. RESULTS: The subjective-objective discrepancy significantly decreased from baseline early on in treatment (following the second session) and were maintained at post-treatment for sleep onset latency, wake after sleep onset (WASO) and sleep efficiency (SE). Total sleep time (TST) discrepancy and misperception decreased from baseline to post-treatment. Improvement in depression symptoms, fatigue symptoms, and negative beliefs about sleep were significantly correlated with the decrease in the discrepancy for WASO and SE. CONCLUSION: These findings suggest that CBT-I resolves the mismatch between objective and subjective sleep parameters early in treatment for adults with insomnia. Sleep misperception improved from underestimating to accurately estimating TST. Improvement of psychological symptoms were related to decrease in sleep discrepancies across treatment. Future research is needed to explore how feedback on objective and subjective sleep discrepancy may impact sleep perception across treatment with CBT-I.

The Worry Behaviors Inventory-Perinatal Revised: Adaptation and Initial Validation for Use in Perinatal Samples.

Generalized anxiety disorder (GAD) is a leading mental health concern during pregnancy and the postpartum (perinatal) period. People with GAD engage in problematic behaviors to manage their distress. However, the extent of GAD behaviors during the perinatal period may not be adequately captured by the Worry Behaviors Inventory (WBI), the most comprehensive measure of GAD behaviors to date. We evaluated the structure of the initial WBI item-pool and then evaluated the internal consistency, construct validity, and predictive utility of the Perinatal Revised WBI (WBI-PR) in a sample of 214 perinatal women with and without GAD. A two-factor, 10-item scale was supported, and some of the retained items differed from the original WBI. Internal consistency of the WBI-PR was acceptable, and evidence of construct validity was demonstrated. The WBI-PR predicted GAD diagnostic status both alone and beyond existing generalized anxiety and depression symptoms. Implications of these findings are discussed.

Sleep effects of psychological therapies for menopausal symptoms in women with hot flashes and night sweats: A systematic review.

Sleep disturbance is frequently reported by women during the menopausal transition due to various physiological changes and environmental factors. Insomnia is a critical treatment target for its deleterious effects on daytime functioning and quality of life and increased risk of developing a depressive disorder. Due to medication side effects and patient preferences, there is increased interest in the use of psychological treatments that address the myriad of menopausal symptoms, including cognitive-behavioural therapy, clinical hypnosis and mindfulness-based therapies. The objective of this article is to review the effects of psychological treatments for menopausal symptoms on sleep disturbance in peri-/postmenopausal women. We conducted a systematic review of the literature using PubMed and reference lists from inception until May 2023, including 12 studies that evaluated sleep as a secondary outcome. Most studies found that group and self-help (guided and unguided) cognitive-behavioural therapies and clinical hypnosis for menopausal symptoms have positive effects on sleep among women with significant vasomotor symptoms. There was preliminary support for mindfulness-based stress reduction. Future research including more diverse samples and women with sleep disorders is needed. Evaluating the implementation of psychological therapies in clinics where menopausal women seek care is an important next step.

Cognitive-behavioral group treatment for menopausal symptoms: a pilot study.

The menopausal transition is frequently accompanied by adverse physical and emotional changes that can significantly impact a woman's quality of life. Hormone replacement therapy has been the most commonly used menopause-related treatment to date, particularly for the alleviation of vasomotor symptoms; recent studies, however, have questioned its long-term safety for some women. We aimed to develop a cognitive-behavioral group treatment (CBGT) program as an alternative or complementary treatment option for reducing the frequency and intensity of debilitating menopausal symptoms in midlife women. Eight subjects participated in two, 10-week pilot groups (n = 4 participants per group) with participants being drawn from referrals through the Women's Health Concerns Clinic and community advertising efforts. This pilot study confirmed a reduction in the frequency and interference associated with vasomotor symptoms, less depression and general anxiety, and an overall improvement in quality of life. Participants also reported high levels of satisfaction with this type of treatment for menopausal symptoms. Furthermore, there was a trend towards a reduction in sleep difficulties and sexual concerns over the course of treatment. This pilot CBGT program appears to be a promising alternative or complementary treatment for both the physical and emotional symptoms experienced during menopause. Further studies are needed on its efficacy through larger, controlled trials.

A pilot study examining the effectiveness of a short-term, DBT informed, skills group for emotion dysregulation during the perinatal period.

The perinatal period (pregnancy and the first-year postpartum) is a time of increased vulnerability to mental health difficulties including emotion dysregulation. Research conducted on treatments targeting emotion dysregulation during this time is limited. Dialectical behavioral therapy (DBT) skills groups are considered the gold standard for targeting emotion dysregulation. We developed and evaluated the effectiveness of a seven-session DBT informed skills group (perinatal emotion regulation skills [Peri-ERS]) tailored to meet the unique emotion dysregulation experienced by women within the perinatal period. N = 41 perinatal women participated in the Peri-ERS group within the Women's Health Concern's Clinic, St. Joseph's Healthcare Hamilton. Participants completed a semistructured assessment to determine eligibility. They completed self-report symptom measures at baseline, Sessions 1-6, and posttreatment assessments. Paired-samples t tests, Cohen's d, and Friedman's rank tests were run to examine change over time. Reliable and clinical change index (RCI) analysis was conducted on emotion dysregulation. Participants demonstrated significant improvements in all symptom domain measures. Forty-eight percent of participants exhibited reliable clinical change on emotion dysregulation. These findings suggest the Peri-ERS group is effective in reducing emotion dysregulation symptoms for perinatal women. These results are promising as this novel treatment addresses a gap in the literature and may potentially be implemented in women's health clinics as a way of improving overall perinatal care. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Problematic behaviours associated with generalized anxiety disorder during pregnancy and the postpartum period: A thematic analysis.

Generalized anxiety disorder (GAD) is one of the most common anxiety disorders in pregnancy and the postpartum (perinatal) period. Perinatal women with GAD engage in problematic behaviours, yet the focus and function of these behaviours remain unknown. OBJECTIVE: Given that worry during the perinatal period is largely maternally focused, the objective of this study was to explore the accompanying behavioural features of GAD during pregnancy and the postpartum period. DESIGN: A qualitative study was conducted. METHODS: Twenty-five pregnant (n = 10) and postpartum (n = 15) women were recruited through clinical referrals and the Hamilton community. Following the completion of a semistructured diagnostic interview and symptom measures, participants participated in one of seven focus groups to learn about behaviours utilized in response to their worries. A thematic analysis was conducted to identify behaviour themes and subthemes in pregnant and postpartum women. RESULTS: Five behaviour themes and 12 subthemes were identified. Specifically, participants endorsed engaging in excessive reassurance seeking, checking and repeating, overcontrol, overpreparation and avoidance behaviours. CONCLUSIONS: Our results confirm that perinatal women with GAD engage in comparable problematic behaviours to those with GAD in the general population, yet the presentation, frequency and focus of those behaviours differ. These findings have implications for theoretical formulations of GAD, and the clinical management of this disorder during the perinatal period.

Intolerance of Uncertainty and Perfectionistic Beliefs About Parenting as Cognitive Mechanisms of Symptom Change During Cognitive Behavior Therapy for Perinatal Anxiety.

OBJECTIVE: A recent randomized controlled trial of group cognitive behavior therapy (CBGT) for perinatal anxiety showed that CBGT is effective in reducing anxiety and depression in pregnant and postpartum women. In secondary analyses, the role of potential mechanisms of symptom change was examined, including intolerance of uncertainty (IU), self-oriented parenting perfectionism (SOPP) and societal-prescribed parenting perfectionism (SPPP). METHOD: The sample included 75 women (Mage = 31.99, SD = 3.57; 37.3% pregnant, 62.7% postpartum) who sought treatment for anxiety and completed the 6-week CBGT or 6-week waitlist within the larger trial. Measures of anxiety (State-Trait Inventory for Cognitive and Somatic Anxiety; STICSA), depression (Edinburgh Postnatal Depression Scale; EPDS), and the proposed mediators (IU, SOPP, SPPP) were completed at baseline and 6-weeks post-baseline. RESULTS: Two moderated mediation models were evaluated to identify potential mediators of the effect of condition (CBGT, waitlist) on anxiety (STICSA; Model 1) or depressive symptoms (EPDS; Model 2). In Model 1, changes in IU partially mediated the effect of condition on anxiety (STICSA) for both pregnant and postpartum women. Changes in SOPP and SPPP were partial mediators for postpartum women only. Change in depression (EPDS) was also a partial mediator for pregnant women in this model. In Model 2, none of the cognitive variables mediated the effect of condition on depressive symptoms (EPDS). However, change in anxiety (STICSA) was a significant mediator of the effect of condition on depression (EPDS) and only among pregnant women. CONCLUSIONS: The results provide support for IU, SOPP and SPPP as mechanisms of change during CBGT and identify differences in important mechanisms among pregnant and postpartum women.

Investigating the relationship between objective measures of sleep and self-report sleep quality in healthy adults: a review.

STUDY OBJECTIVES: Sleep is one of the most common factors related to health, yet a standard definition of sleep quality has not been identified. Polysomnography provides important information about objective sleep variables. However, the relationship between objective sleep variables and perception of sleep quality remains unclear. The purpose of this review was to (1) summarize the current methods of measuring objective sleep macrostructure and microstructure, including electroencephalography arousals, spectral frequency, cyclic alternating pattern, and self-report sleep quality, and (2) investigate the relationship between objective measures of sleep physiology and self-report sleep quality in healthy adults. METHODS: A literature search was conducted using Medline, PubMed, and PsycInfo databases and cited reference searches. Eligible studies included a comparison between self-report sleep quality and polysomnography sleep measures in healthy adults. RESULTS: Thirteen studies were identified. Measurement of self-report sleep quality varied widely across studies. Total sleep time and sleep efficiency were most consistently related to sleep quality, while other objective sleep variables, including electroencephalography spectral analysis, were not reliably predictive of self-report sleep quality in healthy adults. There is preliminary support that microstructural sleep analysis with cyclic alternating pattern may be related to self-reported sleep quality. CONCLUSIONS: Further research is needed to define and standardize self-report measures of sleep quality and investigate the microstructure of sleep. Objective measures of sleep and experiences of "quality" sleep are not as closely related as one may expect in healthy individuals, and understanding this relationship further is necessary to improve the clinical utility of sleep physiology. CITATION: Cudney LE, Frey BN, McCabe RE, Green SM. Investigating the relationship between objective measures of sleep and self-report sleep quality in healthy adults: a review. J Clin Sleep Med. 2022;18(3):927-936.

Impact of the CBT-Meno protocol on menopause-specific beliefs, dysfunctional attitudes, and coping behaviors.

OBJECTIVE: A recent clinical trial demonstrated that a group cognitive-behavioral therapy protocol for menopause (CBT-Meno; Green et al. Menopause 2019;26(9):972-980) was effective in reducing menopausal symptoms, including vasomotor and depressive symptoms. The current analyses evaluated the effectiveness of CBT-Meno in improving menopause-specific beliefs, dysfunctional attitudes associated with depression, and menopause-specific behaviors. METHODS: In a subset of participants from the larger trial, women assigned to CBT-Meno or waitlist and who had completed symptom, cognitive, and behavioral measures at least at baseline were included. Assessments were conducted at baseline, 12 weeks after baseline, and 3 months after treatment. Measures included the Hot Flash Related Daily Interference Scale, the vasomotor subscale of the Greene Climacteric Scale, the Beck Depression Inventory II, the Hot Flush Beliefs Scale, the Dysfunctional Attitudes Scale, and the Hot Flush Behavior Scale (HFBehS). RESULTS: As reported in the main study outcomes (Green et al. Menopause 2019;26(9):972-980), CBT-Meno participants reported greater improvements than waitlist in terms of vasomotor symptom interference and depressive symptoms (Hot Flash Related Daily Interference Scale, Beck Depression Inventory II; partial eta-squared [ η2p ] = 0.15-0.18), although not in vasomotor severity (Greene Climacteric Scale [vasomotor subscale]; η2p = 0.05). CBT-Meno participants reported greater improvements than waitlist in menopause-specific beliefs (Hot Flush Beliefs Scale; η2p = 0.08-0.12), dysfunctional attitudes (Dysfunctional Attitudes Scale; η2p = 0.09), and menopause-specific behaviors (HFBehS; η2p = 0.08-0.12). Within-group analyses showed improvements in CBT-Meno on all variables ( d = 0.38-1.26) except in cooling strategies ( d = 0.18). Gains in CBT-Meno were maintained from posttreatment to 3-month follow-up, although a decrease in positive coping behaviors was observed (HFBehS-positive behavior subscale; d = 0.99). CONCLUSIONS: The CBT-Meno protocol is effective in improving menopause-related symptoms and a broader range of outcomes, including problematic beliefs about menopause, dysfunctional attitudes related to depression, and menopause-specific behaviors.

Cognitive Behavioral Therapy for Sexual Concerns During Perimenopause: A Four Session Study Protocol.

Background: During the menopausal transition, women often experience physical (e.g., vasomotor symptoms) and emotional (e.g., anxiety and depression) difficulties that significantly impact functioning and overall quality of life. Although sexual concerns (e.g., decreased sexual desire, orgasm), are reported by up to 87% of peri- and post-menopausal women, and are associated with adverse impact on functioning and distress, treatment options that directly target this area are limited, and most often involve medication (e.g., hormone replacement). Effectiveness of these treatments is often defined as improvements in physical symptoms, however, associated psychological and emotional symptoms rarely, if at all, improve. Cognitive behavioral therapy (CBT) has been proposed as a low-risk treatment for menopausal symptoms with studies showing improvement in frequently reported symptoms (e.g., vasomotor symptoms, depression, anxiety, sleep). Sexual concerns, however, have either not been directly targeted at all in current CBT protocols, or the very few protocols that include sexual concerns, demonstrated modest gains in sexual desire. Methods: This protocol paper outlines the development, design, and implementation of a newly developed CBT for sexual concerns trial during perimenopause (CBT-SC-Peri). Although sexual concerns are prevalent during both the peri- and post-menopausal periods, we will be evaluating the effectiveness of a CBT-SC protocol specifically for perimenopausal women as a means of early intervention. The clinical sample will comprise 82 women aged 40-60 years currently in perimenopause, as per the Stages of Reproductive Aging Workshop (STRAW) definition, and medication stable (if applicable). To ensure participants are experiencing clinically significant sexual concerns, a baseline cut-off score of 26 or lower on the Female Sexual Functioning Index will be utilized. Exclusion criteria include participants with psychotic disorders, or current substance and/or alcohol dependence, or severely depressed/suicidal. The CBT-SC-Peri is a weekly, four session treatment, lasting up to 90 min per session and includes psychoeducation and cognitive and behavioral strategies designed to challenge unhelpful beliefs and promote healthy sexual behaviors. As this is an individual CBT protocol, content will be tailored to address the specific problems relevant for each participant. Eligible women will be placed directly into treatment or on a 4-week waitlist and reassessed prior to starting treatment. The primary outcome (sexual satisfaction), as well as secondary outcomes (desire, arousal, relationship satisfaction, body image, vasomotor symptoms, depression, and anxiety) are assessed at baseline, post-waitlist (for those on waitlist), and post-treatment. Discussion: To our knowledge, this will be the first study to investigate the efficacy of a CBT protocol (CBT-SC-Peri) specifically aimed at improving sexual concerns experienced during perimenopause. If effective, this form of treatment may not only be preferred by some, but necessary for others as consumer demand increases for non-pharmacological treatments for perimenopausal symptoms. Further, this protocol can be integrated into perimenopausal care and will be made available by dissemination to healthcare practitioners. Clinical Trial Registration: Trial # NCT04922385 and Accessible at: https://clinicaltrials.gov/ct2/show/NCT04922385?term=NCT04922385anddraw=2andrank=1.

Preliminary Support for a Cognitive Remediation Intervention for Women During the Menopausal Transition: A Pilot Study.

Background: Menopause is associated with physical and emotional symptoms, and subjective cognitive concerns that are generally not borne out on objective cognitive measures. This discrepancy suggests that a psychological rather than biological mechanism likely mediates the cognitive concerns of women in menopause. The current study assessed the feasibility and effectiveness of a cognitive remediation intervention with the goal of reducing subjective perceptions of cognitive difficulty during the menopause. Methods: Twenty-seven menopausal women (M age = 53.74, SD = 4.14) completed a 5-week group-based intervention (with a post-group booster) consisting of 2-h weekly sessions. Participants completed pre- and post-intervention measures capturing subjective cognitive ability, mood, anxiety, stress, personality, and objective cognitive tests. The primary variable of interest was self-reported cognitive confidence measured by the Memory and Cognitive Confidence Scale (MACCS). Results: All but one MACCS subscale significantly decreased over the course of treatment (with lower scores associated with higher confidence) and effect sizes ranged from small to large (d = -0.39 to -0.91) with gains maintained at 1-month follow-up. Interestingly, no change in objective cognitive test performance was observed, indicating increases in subjective cognitive confidence in the absence of objective cognitive improvement. There was no change in mood, anxiety, or stress scores. Two-level HLM analyses revealed that those with higher baseline neuroticism, as measured by the NEO Personality Inventory, had smaller decreases in post-group MACCS High Standards subscale relative to those with lower baseline neuroticism (p = 0.027, d = -0.45). Those with higher baseline depression scores on the Depression Anxiety Stress Scale (DASS-21) had a smaller decrease in post-intervention MACCS Total Score relative to those with lower depression ratings. Conclusion: To our knowledge, this is the first feasibility study of its kind targeting perceptions of cognitive impairment during menopause. Although generally well-tolerated, recruitment and scheduling difficulties were flagged as challenges to engagement while a small sample size and lack of control group limit conclusions about efficacy. Providing current results could be replicated with enhanced methods, these results provide support that cognitive remediation is a feasible and credible treatment, and may improve quality of life for women in menopause. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03311880.

Evaluation of an Augmented Cognitive Behavioural Group Therapy for Perinatal Generalized Anxiety Disorder (GAD) during the COVID-19 Pandemic.

The perinatal period is considered a window of vulnerability given the increased risk of psychiatric difficulties during this time, such as mood and anxiety disorders (ADs). Pre-pandemic rates of ADs in perinatal women were one in five but have since increased with the onset of the COVID-19 pandemic (COVID). In addition, recent research suggests that the focus of worry has shifted during the pandemic, with perinatal women reporting significantly more COVID-specific worries. The objective of this study was to augment our current evidence-based Cognitive Behavioural Group Therapy (CBGT) for perinatal anxiety protocol by targeting intolerance of uncertainty and tailoring existing strategies to address COVID-related worry and impact. Pregnant (n = 19) and postpartum (n = 49) women were recruited from regular clinic patient flow from a university-affiliated teaching hospital between September 2020 and March 2021. Improvements in generalized anxiety symptoms, worry, intolerance of uncertainty, and mood were observed at post-treatment, maintained at 3-months, and the intervention received high ratings of treatment satisfaction. This is the first study to examine an augmented CBGT for perinatal women with GAD during the pandemic and supports the inclusion of strategies that target intolerance of uncertainty as well as specific pandemic and perinatal worry content for effective outcomes.